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Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma (LIFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01275209
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : December 5, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with bendamustine in patients with follicular lymphoma.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Drug: HCD122 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib, Multicenter, Open-label Study of HCD122 Administered Intravenously in Combination With Bendamustine in Patients With CD40+ Follicular Lymphoma Who Are Refractory to Rituximab
Study Start Date : February 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: HCD122 Drug: HCD122
Other Name: Lucatumumab


Outcome Measures
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Primary Outcome Measures :
  1. Incidence rate of dose-limiting toxicities and adverse events [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of follicular lymphoma, according to the Revised European American Lymphoma/World Health Organization [REAL/WHO] classification
  • Documented CD40+ follicular lymphoma
  • Measurable lesion
  • Refractory to rituximab
  • Prior treatment with at least 1 chemotherapeutic regimen
  • 18 years or older
  • WHO Performance Status grade 0, 1, or 2
  • Life expectancy > 3 months
  • Obtained written informed consent

Exclusion Criteria:

  • Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma (i.e. DLBCL)
  • History of another primary malignancy that is currently clinically significant or currently requires active intervention
  • Prior allogeneic stem cell transplantation
  • Prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration
  • Impaired cardiac function or clinically significant cardiac disease
  • History of acute or chronic pancreatitis, surgery of the pancreas, or any risk factors that may increase the risk of pancreatitis
  • History of an active infection (viral, bacterial, or fungal) requiring systemic therapy within 28 days before study treatment.
  • Known diagnosis of human immunodeficiency virus (HIV) infection
  • Evidence of previous hepatitis viral infection such as hepatitis B or hepatitis C
  • Ongoing corticosteroid use (>10 mg/day prednisone or equivalent)
  • Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275209


Locations
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United States, Massachusetts
Dana Farber Cancer Institute SC-5
Boston, Massachusetts, United States, 02115
United States, Michigan
Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)
Detroit, Michigan, United States, 48201
United States, North Carolina
Duke University Medical Center Duke Hem & Onc
Durham, North Carolina, United States, 27710
United States, Tennessee
Sarah Cannon Research Institute SC - 2
Chattanooga, Tennessee, United States, 37404
Australia, Victoria
Novartis Investigative Site
Prahran, Victoria, Australia, 3181
Belgium
Novartis Investigative Site
Gent, Belgium, 9000
Novartis Investigative Site
Leuven, Belgium, 3000
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
France
Novartis Investigative Site
Paris, France, 75475
Italy
Novartis Investigative Site
Torino, TO, Italy, 10126
Spain
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08035
Novartis Investigative Site
Madrid, Spain, 28046
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01275209    
Other Study ID Numbers: CHCD122A2104
2010-022350-17 ( EudraCT Number )
First Posted: January 12, 2011    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: December 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
HCD122
Lucatumumab
CD40
 Follicular Lymphoma
Non-Hodgkin's Lymphoma
Antibody
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin